Polivy
polatuzumab vedotin
Table of contents
Overview
Polivy is a cancer medicine used to treat adults with diffuse large B-cell lymphoma (DLBCL) whose cancer has returned or has stopped responding to other treatments and who cannot have a bone-marrow transplantation.
It is used in combination with two other medicines, bendamustine and rituximab.
DLBCL is rare, and Polivy was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 16 April 2018.
Polivy contains the active substance polatuzumab vedotin.
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List item
Polivy : EPAR - Medicine overview (PDF/130.77 KB)
First published: 27/01/2020
EMA/24757/2020 -
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List item
Polivy : EPAR - Risk-management-plan summary (PDF/539.41 KB)
First published: 27/01/2020
Last updated: 15/12/2020
Authorisation details
Product details | |
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Name |
Polivy
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Agency product number |
EMEA/H/C/004870
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Active substance |
polatuzumab vedotin
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International non-proprietary name (INN) or common name |
polatuzumab vedotin
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Therapeutic area (MeSH) |
Lymphoma, B-Cell
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Anatomical therapeutic chemical (ATC) code |
L01XC
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Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Conditional approval |
This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation. |
Orphan |
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation. |
Publication details | |
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Marketing-authorisation holder |
Roche Registration GmbH
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Revision |
2
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Date of issue of marketing authorisation valid throughout the European Union |
16/01/2020
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Contact address |
Product information
09/12/2020 Polivy - EMEA/H/C/004870 - R/0003
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
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Monoclonal antibodies
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Other antineoplastic agents
Therapeutic indication
Polivy in combination with bendamustine and rituximab is indicated for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant.